Method of forming barbs on a suture

ABSTRACT

A method is provided for forming a barbed medical device which includes the steps of providing a blank workpiece and forming at least one barb on the blank workpiece by applying vibrational energy to a tool and bringing the tool and the blank workpiece into contact with each other at an angle such that the tool cuts into the surface of the blank workpiece. A barbed medical device formed by this method is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application No. 60/994,173, filed Sep. 17, 2007, the entiredisclosure of which is incorporated by reference herein.

TECHNICAL FIELD

The present disclosure relates to a method of forming barbs on medicaldevices, namely forming barbs on sutures using vibrational energy. Moreparticularly, the present disclosure relates to a method of formingbarbs on sutures using ultrasonic energy.

BACKGROUND OF RELATED ART

Barbed sutures are generally made of the same materials as conventionalsutures and offer several advantages for closing wounds compared withconventional sutures. A barbed suture includes an elongated body thathas one or more spaced barbs, that project from the surface of thesuture body along the body length. The barbs are arranged to allowpassage of the barbed suture in one direction through tissue but resistmovement of the barbed suture in the opposite direction. Thus, oneadvantage of barbed sutures has been the provision of a non-slipattribute.

Barbed sutures are known for use in cosmetic, laparoscopic andendoscopic procedures. The number of barbs called for on a particularsuture may be influenced by the size of the wound and the strengthrequired to hold the wound closed. Like a conventional suture, a barbedsuture may be inserted into tissue using a surgical needle.

In some circumstances, a random configuration of barbs on the exteriorsurface of the suture is preferred to achieve optimal wound closureholding for the particular wound. However, in other circumstances, wherethe wound or tissue repair needed is relatively small, a reduced numberof barbs may be desired. In other circumstances, a two way barbed sutureis desirable where the barbs permit passing of the suture in onedirection over a portion of the suture and barbs permitting passing ofthe suture in a second direction over another portion of the suture toperform a tight closing stitch.

Various methods of forming barbs on sutures have been proposed such asmechanical cutting, laser cutting, injection molding, stamping,extrusion and the like. However, such methods may be difficult or costlyto achieve the desired result with respect to getting the arrangement ofbarbs in a configuration needed for the appropriate procedure and fordoing so in an efficient cost effective manner.

Conventional cutting methods of forming barbs have significant drawbacksin their ability to maintain sharpness, move rapidly, part cost and haveslow manufacturing cycle time.

Accordingly, there is a continuing need for methods of forming barbs ona suture that are less difficult, more effective and economical. Thereis also a continuing need for methods which are able to vary the size ofthe barbs, the location and the depth, as well as a need for determiningthe amount of the barbs needed on a suture for the type of tissue to berepaired.

SUMMARY

A method is provided for forming a barbed medical device which includesthe steps of providing a blank workpiece and forming at least one barbon the blank workpiece by applying vibrational energy to a tool andbringing the tool and the blank workpiece into contact at an angle suchthat the tool cuts into the surface of the blank workpiece.

The tool provided may be a knife or rotary blade formed of geometricalshapes such as a rectangle, a square, a circle, flat, a star, anoctagon, a triangle, a spade, an arrow, a key and an ellipse.

In exemplary embodiments, the vibrational energy may be ultrasonicenergy and is applied to the blank workpiece by providing a converterwhich communicates ultrasonic energy to a horn operatively coupled tothe converter.

A barbed medical device formed by the method in accordance with thepresent disclosure is provided.

A method is provided for forming a barbed suture which includes thesteps of providing a suture and forming at least one barb on the sutureby applying vibrational energy to a tool and bringing the tool and thesuture into contact at an angle such that the tool cuts into the surfaceof the suture. A method of closing a wound with the barbed suture formedby the method in accordance with the present disclosure is alsoprovided.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure will be described hereinbelow with reference to the figures wherein:

FIG. 1 is a perspective view of a barbed suture formed in accordancewith the present disclosure;

FIGS. 2A-G are partial perspective views of alternative embodiments ofthe geometry of blank workpieces in accordance with the presentdisclosure;

FIG. 3 is a schematic view of one embodiment of an apparatus and methodof forming barbs on a blank workpiece in accordance with the presentdisclosure; and

FIGS. 4A-M are transverse cross-sectional views of alternativeembodiments of the geometry of the knife blade shape in accordance withthe present disclosure.

DETAILED DESCRIPTION

In general, disclosed herein is a method of forming a barbed medicaldevice by providing a blank workpiece and forming at least one barb onthe blank workpiece by vibrating a tool, such as a knife, with energyand bringing the knife and the workpiece in contact with one another tocut into the surface of the workpiece a predetermined depth, angle, andlength thereby forming a barb. The present disclosure illustrates anddescribes the method by way of the illustrative example of applyingultrasonic energy to the tool, e.g., knife. However, it is contemplatedand within the scope of the present disclosure that the tool or knifemay be vibrated by other forms of energy.

Referring now in detail to the drawings in which like reference numeralsare having an elongated body 14 and a plurality of barbs 12 formedthereon.

The medical device 10 has a proximal and distal end. As shown in theexemplary embodiment of FIG. 1, the barbs 12 may be formed projectingfrom the blank workpiece 29 towards at least one end. In otherembodiments, multiple barbs may be formed such that a portion of thebarbs project toward one end and the remaining portion of the barbsproject toward the other end so as to form a two way medical device. Thebarbs 12 as formed have an angle of less than 90 degrees between thebarbs 12 and the wound closure elongated body 14.

The blank workpiece 29 in accordance with the present disclosure may beformed of the type selected from the group consisting of monofilamentsutures, braided sutures, multifilament sutures, surgical fibers,anchors, slit sheets, ribbons, tape, mesh, stent, scaffolds, pledgets,vascular graft and ribbons.

The blank workpiece from which the exemplary medical device 10 of FIG. 1is formed is circular in cross-sectional geometry. However, thecross-sectional geometry of the blank workpiece may be of any suitableshape. For example, FIGS. 2A-2G illustrate cross-sectional views ofalternative embodiments of the various cross-sectional geometries of theblank workpiece in accordance with the present disclosure, namely, round(FIG. 2A), elliptical (FIG. 2B), square (FIG. 2C), star shaped (FIG.2D), octagonal (FIG. 2E), rectangular (FIG. 2F), and flat (FIG. 2G).

FIG. 3 illustrates an embodiment of an apparatus and method of formingbarbs in accordance with the present disclosure. In the illustrativeembodiment of FIG. 3, the ultrasonic energy is generated by an apparatus20 that includes a converter 22 which transmits ultrasonic energy to ahorn 26 that is operatively coupled to the converter 22. The converter22 converts electrical energy to mechanical energy which causesdisplacement of the tool at a predetermined ultrasonic frequency poweredby an ultrasonic generator or booster 28. Booster 28 may be manipulatedto either increase or decrease the ultrasonic frequency which may betransmitted to the tool. The ultrasonic frequency may range from about 1kHz to about 100 kHz. In other embodiments, the ultrasonic frequency mayrange from about 10 kHz to about 90 kHz. In still further embodiments,the ultrasonic frequency may range from about 15 kHz to about 50 kHz.The ultrasonic signal amplitude may range from about 1μ to about 125μ.In other embodiments, the signal amplitude may range from about 15μ toabout 60μ.

The depth and the angle of the barbs relative to the elongated body ofthe medical device are variable based on the signal amplitude ofultrasonic energy applied to the cutting element. For example, as theultrasonic amplitude is increased, the ratio of the cut and the angle ofthe barbs are decreased. As the ultrasonic amplitude is increased, thedepth of the cut is increased.

With continued reference to FIG. 3, the apparatus 20 optionally includesa gripper such as anvil 30 for supporting a blank workpiece 29. Thegripper 30 supports the blank workpiece 29 at a fixed position. The horn26 is configured and dimensioned to accept a knife blade, a rotary blade(not shown) or the like for forming the barbs on the blank workpiece.Apparatus 20 optionally includes camera 32 for recording the method offorming barbs and a light source 34 for optimizing the view of camera32. The motorized slide 34 moves in an X, Y, and Z plane to allow theblank workpiece to pass in front of the converter to form barbs thereon.Apparatus 20 also includes rotational motor 36 which rotates the blankworkpiece in a circular direction. Advance slide 38 moves the blankworkpiece after every cut a predetermined increment for the appropriatebarb spacing.

In embodiments, the blank workpiece is moved in a linear orperpendicular motion relative to the horn. The amount of time the bladeis in contact with the blank workpiece ranges, in embodiments, fromabout 1 millisecond to about 5 seconds. In other embodiments, the amountof time the blade is in contact with the blank workpiece ranges fromabout 1 second to about 3 seconds. In still further embodiments, theamount of time the blade is in contact with the blank workpiece is about2 seconds.

FIGS. 4A through 4M illustrate alternative embodiments of variousgeometries of an ultrasonic knife blade in accordance with the presentdisclosure, namely, a circle (FIG. 4A), an ellipse (FIG. 4B), a square(FIG. 4C), a star (FIG. 4D), an octagon (FIG. 4E), a rectangle (FIG.4F), a flat shape (FIG. 4G), a triangle (FIG. 4J), a key (FIG. 4K), aspade (FIG. 4L), an arrow (FIG. 4M), and combinations thereof. Thecurvature of the rotary blade may also include a substantially concaveshape (FIG. 4H) and a substantially convex shape (FIG. 4I).

In practice, the blank workpiece passes in front of the converter 22which includes the horn 26 and the anvil 30, then using ultrasonicenergy at various frequencies and signal amplitudes cut the material toa predetermined geometry. In embodiments, the blank workpiece passes infront of the converter via motorized slide 34 which is configured anddimensioned to hold gripper 30 and camera 32 thereon. In certainembodiments, the blank workpiece passes in front of converter 22, via amechanical feeding mechanism with the blank workpiece held tightlyaround two spools on each side of the apparatus (not shown). In otherembodiments, the blank workpiece passes in front of converter 22 viahuman manipulation of the blank workpiece.

The apparatus includes a converter 22 coupled to a horn 26 whichoperatively moves along a straight line X-Y plane via ultrasonicvibrational energy. The horn 26 includes a blade which contacts asurface of the blank workpiece at an angle so as to form at least onebarb on the blank workpiece. The blade is appropriately positioned tocontact the blank workpiece via knife positioning slide 40. After eachbarb is formed, the blank workpiece is moved in a linear motion on a X-Yplane via motorized slide 34 a predetermined length to allow anotherbarb to be formed thereon. In embodiments, the blank workpiece is movedin a X-Z plane via motorized slide 34 a predetermined length to form abarb thereon. In further embodiments, the blank workpiece is moved in aY-Z plane via motorized slide 34 a predetermined length to form a barbthereon. In alternative embodiments, the blank workpiece is moved in acircular manner via rotational motor 36 to form a barb at apredetermined position. In embodiments, the blank workpiece is moved inboth a rotational and x-z plane rotation.

In practice, the barbs 12 are formed as either the knife blade 24 orrotary blade (not shown) contacts the outer surface of the blankworkpiece 29. The blade may be urged into contact with the surface ofthe blank workpiece 29, for example, by a reciprocating actuator in astraight line X-Y plane. It is contemplated, however, that inalternative embodiments, the blade may be held fixed and the workpiece29 may be urged toward the blade. The blade makes contact with thesurface of the blank workpiece 29 at an angle relative thereto such thatthe combined action of the movement of the blade into contact with theworkpiece surface and the ultrasonic vibration of the knife forms thedesired barb. Advance slide 38 then moves the blank workpiece afterevery cut a predetermined increment for the desired spacing of thebarbs.

Ultrasonic energy may transfer heat to the blank workpiece 29 as it isforming the barbs 12 thereon. Depending on the strength of theamplitude, the ultrasonic frequency may cause melting of blank workpiece29 if the blades are left to penetrate blank workpiece 29 throughout thefull wave cycle. To prevent this from occurring, in some embodiments,the application of ultrasonic energy is discontinued at some point priorto withdrawal of the blades from contact of the blank workpiece 29. Inother embodiments, this method may be used to vary the angle and thedepth of the cut as indicated above with respect to the increase ordecrease of the amplitude.

In some embodiments, barbs may be formed by making acute angular cutsdirectly into the blank workpiece body, with cut portions pushedoutwardly and separated from the body of the blank workpiece. The depthof the barbs thus formed in the blank workpiece body may depend on thediameter of the material and the depth of the cut.

In some embodiments, a suitable device for cutting a plurality ofaxially spaced barbs on the exterior of a filament may use an gripper asa cutting bed, a cutting bed vise, a cutting template, and an converterand horn as the blade assembly to perform the cutting. In operation, thecutting device has the ability to produce a plurality of axially spacedbarbs in the same or random configuration and at different angles inrelation to each other.

In other embodiments, the barbs may be aligned on a first portion of alength of the blank workpiece body to allow movement of a first end ofthe medical device through tissue in one direction, while barbs on asecond portion of the length of the blank workpiece body may be alignedto allow movement of the second end of the medical device in an oppositedirection.

The barbs may be arranged in any suitable pattern, for example, helical,linear, or randomly spaced. The pattern may be symmetrical orasymmetrical. The number, configuration, spacing and surface area of thebarbs may vary depending upon the tissue in which the medical device isused, as well as the composition and geometry of the material utilizedto form the medical device. Additionally, the proportions of the barbsmay remain relatively constant while the overall length of the barbs andthe spacing of the barbs may be determined by the tissue beingconnected. For example, if the medical device is to be used to connectthe edges of a wound in skin or tendon, the barbs may be made relativelyshort and more rigid to facilitate entry into this rather firm tissue.Alternatively, if the medical device is intended for use in fattytissue, which is relatively soft, the barbs may be made longer andspaced further apart to increase the ability of the suture to grip thesoft tissue.

The surface area of the barbs may also vary. For example, fuller-tippedbarbs may be made of varying sizes designed for specific surgicalapplications. For joining fat and relatively soft tissues, larger barbsmay be desired, whereas smaller barbs may be more suitable forcollagen-dense tissues. In some embodiments, a combination of large andsmall barbs within the same structure may be beneficial, for examplewhen a suture is used in tissue repair with differing layer structures.Use of the combination of large and small barbs with the same suturewherein barb sizes are customized for each tissue layer will ensuremaximum anchoring properties. In particular embodiments, a singledirectional suture may have both large and small barbs; in otherembodiments a bi-directional suture may have both large and small barbs.The barbs formed may include geometrical shapes such as round,triangular, square, oblique, elliptical, octagonal, rectangular, andflat

In some embodiments, barbs may be formed on the outer surface of anchorswhich allow movement of the anchor portion through bone in one directionbut resist the withdrawal of the anchor portion after the anchor portionhas been implanted in the bone.

Blank workpieces 29 in accordance with the present disclosure may beformed of degradable materials, non-degradable materials, andcombinations thereof. More particularly, the blank workpiece may beformed of a degradable material selected from the group consisting ofpolyesters, polyorthoesters, polymer drugs, polydroxybutyrates,lactones, proteins, cat gut, collagens, carbonates, homopolymersthereof, copolymers thereof, and combinations thereof. In otherembodiments, suitable degradable materials which may be utilized to formthe medical device include natural collagenous materials or syntheticresins including those derived from alkylene carbonates such astrimethylene carbonate, tetramethylene carbonate, and the like,caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide,homopolymers thereof, copolymers thereof, and combinations thereof. Insome embodiments, glycolide and lactide based polyesters, especiallycopolymers of glycolide and lactide, may be utilized to form the blankworkpiece of the present disclosure.

Barbed medical devices fabricated from a degradable material inaccordance with the present disclosure maintain their structuralintegrity after implantation for a predetermined period of time,depending on the characteristics of the particular copolymer used. Suchcharacteristics include, for example, the components of the copolymer,including both the monomers utilized to form the copolymer and anyadditives thereto, as well as the processing conditions (e.g., rate ofcopolymerization reaction, temperature for reaction, pressure, etc.),and any further treatment of the resulting copolymers, i.e., coating,sterilization, etc.

Barbed sutures of the present disclosure typically maintain theirstructural integrity. For example, the Maxon™ suture, commerciallyavailable from U.S. Surgical, a division of Tyco Healthcare, typicallymaintains 80% of initial tensile strength at 1 week, 75% at 2 weeks, 65%at 3 weeks, 50% at 4 weeks and 25% at 6 weeks post implant. Anotherexample includes Caprosyn™, commercially available from U.S. Surgical, adivision of Tyco Healthcare, which provides strong secure woundapproximation for 10 days and maintains structural integrity even aftermultiple passes.

The formation of barbs on a suture body may be utilized to change thedegradation time of a suture in accordance with the present disclosureas described in U.S. patent application Ser. No. 11/556,002 filed onNov. 2, 2006 entitled “Long Term Bioabsorbable Barbed Sutures”, theentire contents of which are incorporated by reference herein.

For non-degradable barbed medical devices constructed in accordance withthe present disclosure, suitable non-degradable materials which may beutilized to form the medical device include polyolefins, such aspolyethylene, polypropylene, copolymers of polyethylene andpolypropylene, and blends of polyethylene and polypropylene; polyamides(such as nylon); polyamines, polyimines, polyesters such as polyethyleneterephthalate; polytetrafluoroethylene; polyether-esters such aspolybutester; polytetramethylene ether glycol; 1,4-butanediol;polyurethanes; and combinations thereof. In other embodiments,non-degradable materials may include silk, collagen, cotton, linen,carbon fibers, and the like. The polypropylene may be isotacticpolypropylene or a mixture of isotactic and syndiotactic or atacticpolypropylene.

The filaments and fibers used for forming the blank workpiece of thepresent disclosure may be formed using any technique within the purviewof those skilled in the art, such as, for example, extrusion, moldingand/or solvent casting.

In some embodiments, the suture of the present disclosure may include ayarn made of more than one filament, which may contain multiplefilaments of the same or different materials. Where the sutures are madeof multiple filaments, the suture may be made using any known techniquesuch as, for example, braiding, weaving or knitting. The filaments mayalso be combined to produce a non-woven suture. The filaments themselvesmay be drawn, oriented, crinkled, twisted, comingled or air entangled toform yarns as part of the suture forming process. In one embodiment, amultifilament suture of the present disclosure may be produced bybraiding. The braiding may be done by any method within the purview ofthose skilled in the art.

Once the medical device is barbed, it may be sterilized by any meanswithin the purview of those skilled in the art.

Medical devices in accordance with the present disclosure may be coatedor impregnated with one or more medico-surgically useful substanceswhich accelerate or beneficially modify the healing process when themedical device is applied to a wound or surgical site. In certainembodiments, the coating may be formed from degradable polymers selectedfrom the group consisting of lactones, carbonates, polyorthoesters,hydroxyalkoanates, hydroxybutyrates, bioactive agents, polyanhydrides,silicone, calcium stearoyl lactylates, vinyl polymers, high molecularweight waxes and oils, natural polymers, proteins, polysaccharides,suspendable particulates, dispersible particulates, microspheres,nanospheres, rods, homopolymers thereof, copolymers thereof, andcombinations thereof.

Suitable bioactive agents include, for example, biocidal agents,antimicrobial agents, antibiotics, anti-proliferatives, medicants,growth factors, anti-clotting agents, clotting agents, analgesics,anesthetics, anti-inflammatory agents, wound repair agents and the like,chemotherapeutics, biologics, protein therapeutics, monoclonal orpolyclonal antibodies, DNA, RNA, peptides, polysaccharides, lectins,lipids, probiotics, diagnostic agents, angiogenics, anti-angiogenicdrugs, polymeric drugs, and combinations thereof.

Bioactive agents include substances which are beneficial and tend topromote the healing process. For example, a suture can be provided witha bioactive agent that will be deposited at the sutured site. Thebioactive agent can be chosen for its antimicrobial properties,capability for promoting wound repair and/or tissue growth, or forspecific indications such as thrombosis. In embodiments, combinations ofsuch agents may be applied to the medical device of the presentdisclosure after formation of the barbs.

The term “antimicrobial agent” as used herein includes an agent which byitself or through assisting the immune system, helps the body destroy orresist microorganisms which may be pathogenic. An antimicrobial agentincludes antibiotics, antiseptics, quorum sensing blockers, antifungals,anti-virals, surfactants, metal ions, antimicrobial proteins andpeptides, antimicrobial polysaccharides, disinfectants and combinationsthereof. Antimicrobial agents which are slowly released into the tissuecan be applied in this manner to aid in combating clinical andsub-clinical infections in a surgical or trauma wound site. Inembodiments, suitable antimicrobial agents may be soluble in one or moresolvents.

In embodiments, the following anti-microbial agents may be used alone orin combination with other bioactive agents described herein: ananthracycline, doxorubicin, mitoxantrone, a fluoropyrimidine,5-fluorouracil (5-FU), a folic acid antagonist, methotrexate,mitoxantrone, quorum sensing blocker, brominated or halogenatedfuranones, a podophylotoxin, etoposide, camptothecin, a hydroxyurea, aplatinum complex, cisplatin, doxycycline, metronidazole,trimethoprim-sulfamethoxazole, rifamycins like rifampin, a fourthgeneration penicillin (e.g., a ureidopenicillin a carboxypenicillin,meziocillin, piperacillin, carbenicillin, and ticarcillin, and ananalogue or derivative thereof), a first generation cephalosporin (e.g.,cephazolin sodium, cephalexin, cefazolin, cephapirin, and cephalothin),a carboxypenicillin (e.g., ticarcillin), a second generationcephalosporin (e.g., cefuroxime, cefotetan, and cefoxitin), a thirdgeneration cephalosporin (e.g., naxcel, cefdinir, cefoperazone,ceftazidime, ceftriaxone, and cefotaxime), polyvinyl pyrrolidone (PVP),a fourth generation cephalosporin (e.g., cefepime), a monobactam (e.g.,aztreonam), a carbapenem (e.g., imipenem, ertapenem and meropenem), anaminoglycoside (e.g., streptomycin, gentamicin, tobramycin, andamikacin), an MSL group member (e.g., a macrolide, a long actingmacrolide, a lincosamide, a streptogramin, Erythromycin, Azithromycin,Clindamycin, Syneroid, clarithromycin, and kanamycin sulfate),tetracyclines like minocycline, fusidic acid, trimethoprim,metronidazole; a quinolone (e.g., ciprofloxacin, ofloxacin,gatifloxacin, moxifloxacin, levofloxacin, and trovafloxacin), a DNAsynthesis inhibitor (e.g., metronidazole), a sulfonamide (e.g.sulfamethoxazole, trimethoprim, including cefixime, spectinomycin,tetracycline, nitrofurantoin, polymyxin B, and neomycin sulfate),beta-lactam inhibitors like sulbactam, chloramphenicol, glycopeptideslike vancomycin, mupirocin, polyenes like amphotericin B, azoles likefluconazole, and other known antimicrobial agent known in the art.

Examples of chemotherapeutics which may be utilized include one or moreof the following: doxorubicin (Dox), paclitaxel (PTX), or camptothecin(CPT), polyglutamate-PTX (CT-2103 or Xyotax),N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer, anthracycline,mitoxantrone, letrozole, anastrozole, epidermal growth factor receptorinhibitors, tyrosine kinase inhibitors, modulators of apoptosis,anthracycline antibiotics such as daunorubicin and doxorubicin,alkylating agents such as cyclophosphamide and melphalan,antimetabolites such as methotrexate and 5-fluorouracil, poly(ethyleneglycol) (PEG), poly(glutamic acid) (PGA), polysaccharides, monoclonalantibody and polymer-drug conjugates thereof, copolymers thereof andcombinations thereof.

The clotting agents include one or more of the following: a fibrosingagent that promotes cell regeneration, a fibrosing agent that promotesangiogenesis, a fibrosing agent that promotes fibroblast migration, afibrosing agent that promotes fibroblast proliferation, a fibrosingagent that promotes deposition of extracellular matrix, a fibrosingagent that promotes tissue remodeling, a fibrosing agent that is adiverticular wall irritant, silk (such as silkworm silk, spider silk,recombinant silk, raw silk, hydrolyzed silk, acid-treated silk, andacylated silk), talc, chitosan, bleomycin or an analogue or derivativethereof, connective tissue growth factor (CTGF), metallic beryllium oran oxide thereof, copper, saracin, silica, crystalline silicates, quartzdust, talcum powder, ethanol, a component of extracellular matrix,oxidized cellulose, polysaccharides, collagen, fibrin, fibrinogen,poly(ethylene terephthalate), poly(ethylene-co-vinylacetate),N-carboxybutylchitosan, an RGD protein, a polymer of vinyl chloride,cyanoacrylate, crosslinked poly(ethylene glycol)-methylated collagen, aninflammatory cytokine, TGFβ, PDGF, VEGF, TNFa, NGF, GM-CSF, IGF-a, IL-1,IL-8, IL-6, a growth hormone, a bone morphogenic protein, a cellproliferative agent, dexamethasone, isotretinoin, 17-β-estradiol,estradiol, diethylstibesterol, cyclosporine a, all-trans retinoic acidor an analogue or derivative thereof, wool (including animal wool, woodwool, and mineral wool), cotton, bFGF, polyurethane,polytetrafluoroethylene, activin, angiopoietin, insulin-like growthfactor (IGF), hepatocyte growth factor (HGF), a colony-stimulatingfactor (CSF), erythropoietin, an interferon, endothelin-1, angiotensinII, bromocriptine, methylsergide, fibrosin, fibrin, an adhesiveglycoprotein, proteoglycan, hyaluronan, secreted protein acidic and richin cysteine (SPaRC), a thrombospondin, tenacin, a cell adhesionmolecule, dextran based particles, an inhibitor of matrixmetalloproteinase, magainin, tissue or kidney plasminogen activator, atissue inhibitor of matrix scavenge tissue-damaging free radicals, tumornecrosis factor for cancer therapy, colony stimulating factor,interferon, interleukin-2 or other lymphokines to enhance the immunesystem, platelet rich plasma, thrombin, peptides such as self assemblypeptide systems, amino acids such as radA based amino acids, hydrogelssuch as super absorbing hydrogel materials, combinations thereof, and soforth.

A wide variety of anti-angiogenic factors may be readily utilized withinthe context of the present disclosure. Representative examples includeAnti-Invasive Factor; retinoic acid and derivatives thereof; paclitaxela highly derivatized diterpenoid; Suramin; Tissue Inhibitor ofMetalloproteinase-1; Tissue Inhibitor of Metalloproteinase-2;Plasminogen Activator Inhibitor-1; Plasminogen Activator Inhibitor-2;various forms of the lighter “d group” transition metals such as, forexample, vanadium, molybdenum, tungsten, titanium, niobium, and tantalumspecies and complexes thereof; Platelet Factor 4; Protamine Sulphate(Clupeine); Sulphated Chitin Derivatives (prepared from queen crabshells); Sulphated Polysaccharide Peptidoglycan Complex (SP-PG) (thefunction of this compound may be enhanced by the presence of steroidssuch as estrogen, and tamoxifen citrate); Staurosporine; Modulators ofMatrix Metabolism, including for example, proline analogs{[(L-azetidine-2-carboxylic acid (LACA), cishydroxyproline,d,L-3,4-dehydroproline, Thiaproline, α,α-dipyridyl, β-aminopropionitrilefumarate; MDL 27032 (4-propyl-5-(4-pyridinyl)-2(3H)-oxazolone;Methotrexate; Mitoxantrone; Heparin; Interferons; 2 Macroglobulin-serum;ChIMP-3; Chymostatin; β-Cyclodextrin Tetradecasulfate; Eponemycin;Camptothecin; Fumagillin Gold Sodium Thiomalate (“GST”); D-Penicillamine(“CDPT”); β-1-anticollagenase-serum; α2-antiplasmin; Bisantrene;Lobenzarit disodium (N-(2)-carboxyphenyl-4-chloroanthronilic aciddisodium or “CCA”; Thalidomide; Angostatic steroid; AGM-1470;carboxynaminolmidazole; metalloproteinase inhibitors such as BB94,analogues and derivatives thereof, and combinations thereof.

A wide variety of polymeric drugs may be readily utilized within thecontext of the present disclosure. Representative examples includesteroidal anti-inflammatory agents, non-steroidal anti-inflammatoryagents, and combinations thereof. Examples of the non-steroidalanti-inflammatory agent which may be used with the present disclosureare aspirin, indomethacin, ibuprofen, phenylbutazone, diflusinal, andcombinations thereof.

Examples of the steroidal anti-inflammatory agent which may be used areglucocorticoids such as cortisone and hydrocortisone, betamethasone,dexamethasone, fluprednisolone, prednisone, methylprednisolone,prednisolone, triamcinolone, paramethasone, and combinations thereof.

Although the above bioactive agents have been provided for the purposesof illustration, it should be understood that the present disclosure isnot so limited. In particular, although certain bioactive agents arespecifically referred to above, the present disclosure should beunderstood to include analogues, derivatives and conjugates of suchagents.

Medical devices in accordance with this disclosure may also include, forexample, biologically acceptable plasticizers, antioxidants andcolorants, which may be impregnated into the filament(s) utilized toform a suture of the present disclosure or included in a coatingthereon.

Bioactive agents may be applied onto a barbed medical device of thepresent disclosure utilizing any method within the purview of oneskilled in the art including, for example, dipping, spraying, vapordeposition, brushing, solvent evaporation, compounding and the like. Inembodiments, a bioactive agent may be deposited within the barb angles,that is, the angle formed between the barb and the blank workpiecesurface in accordance with the present disclosure as described in U.S.patent application Ser. No. 11/899,852 filed on Sep. 6, 2007 entitled“Bioactive Substance in a Barbed Sutures”, the entire contents of whichare incorporated by reference herein.

Placement of a bioactive agent in the angle formed between the barbs andblank workpiece surface places the bioactive agent at precisely definedlocations within a tissue wound closure, which thereby provides a uniquecontrolled and sustained release dosage form.

Blank workpieces of the present disclosure may be dyed in order toincrease the visibility of the workpiece in the surgical field. Any dyesuitable for incorporation in medical devices may be used. Such dyesinclude, but are not limited to, carbon black, bone black, D&C Green No.6, and D&C Violet No. 2. Filaments in accordance with the presentdisclosure may be dyed by adding dye in an amount up to about a fewpercent; in other embodiments, they may be dyed by adding dye in anamount of about 0.2%; in still further embodiments, the dye may be addedin an amount from about 0.06% to about 0.08%.

The filaments and sutures of the present disclosure may additionallycomprise a needle at one end. In order to facilitate needle attachmentto a suture of the present disclosure, conventional tipping agents maybe applied to the braid. Two tipped ends of the suture may be desirablefor attaching a needle to each end of the suture to provide a so-calleddouble armed suture. The needle attachment may be made by anyconventional method such as crimping, swaging, and the like.

In some cases, a tubular insertion device (not shown) may be utilized tointroduce a barbed medical device in accordance with the presentdisclosure into tissue. Such a tubular insertion device may have atubular body in which the barbed medical device of the presentdisclosure is disposed, as well as a distal end and a proximal end. Insome embodiments, the pointed end of a barbed suture of the presentdisclosure may be pushed with the distal end of the tubular insertiondevice through skin, tissue, and the like at an insertion point. Thepointed end of the suture and the distal end of the tubular insertiondevice are pushed through the tissue until reaching an endpoint. Theproximal end of the tubular insertion device is then gripped and pulledto remove the insertion device, leaving the barbed suture in place.

Barbed sutures and placement methods suitable for use according to thepresent disclosure are well known in the art. For example, inembodiments, medical devices of the present disclosure may be utilizedto provide lift to tissue, which may be desirable in certain cosmeticapplications. In some embodiments, a procedure for closing tissueutilizing barbed sutures includes inserting a first end of the suture,optionally attached to a needle, at an insertion point on the surface ofa person's body. The first end of the suture may be pushed through softtissue until the first end extends out of the soft tissue at an exitpoint. The first end of the suture may then be gripped and pulled todraw the first portion of the suture through the soft tissue so that alength of the first portion of the suture remains in the soft tissuebetween the point of insertion and exit point of the first end. The softtissue may then be manually grouped and advanced along at least oneportion of the suture to provide the desired amount of lift.

The medical devices of the present disclosure may be utilized in anycosmetic, orthopedic, open endoscopic or laparoscopic methods. Inaddition, sutures of the present disclosure may be utilized to attachone tissue to another including, but not limited to, attaching tissue toa ligament. Specific applications of cosmetic surgeries include, forexample, facelifts, browlifts, thigh lifts, and breast lifts.

While the above description contains many specifics, these specificsshould not be construed as limitations on the scope of the disclosure,but merely as exemplifications of embodiments thereof. Those skilled inthe art will envision many other possibilities within the scope andspirit of the disclosure as defined by the claims appended hereto.

1. A method of forming a barbed medical device comprising the steps of:providing a blank workpiece defining a horizontal axis; and forming atleast one barb on the blank workpiece by; applying vibrational energy toa tool; translating the blank workpiece along an axis transverse to thehorizontal axis towards the tool; and bringing the tool and the blankworkpiece into contact at an angle such that the tool cuts into thesurface of the blank workpiece.
 2. The method according to claim 1,wherein the vibrational energy is ultrasonic energy.
 3. The methodaccording to claim 2, wherein the applying step further includesproviding a converter which transmits ultrasonic energy to a hornoperatively coupled to the converter.
 4. The method of claim 3, whereinthe converter includes a horn and a booster to either increase ordecrease ultrasonic frequency.
 5. The method of claim 4, furthercomprising the step of providing a frequency such that heat is generatedbetween the tool and the blank workpiece, a cut being shaped by theheat.
 6. The method of claim 3, further comprising a blade and whereinthe horn is configured and dimensioned to accept the blade.
 7. Themethod according to claim 6, wherein the blade is selected from thegroup consisting of a linear knife blade and a rotary blade.
 8. Themethod according to claim 7, wherein the knife blade is a shape selectedfrom the group consisting of rectangle, a square, a circle, flat, astar, an octagon, a triangle, a spade, an arrow, a key, an ellipse andcombinations thereof.
 9. The method according to claim 8, wherein acurvature of the knife blade is substantially concave.
 10. The methodaccording to claim 8, wherein a curvature of the knife blade issubstantially convex.
 11. The method according to claim 2, furthercomprising providing an anvil for supporting the blank workpiece. 12.The method according to claim 2, wherein the ultrasonic frequency rangesfrom about 1 to about 100 kHz.
 13. The method according to claim 12,wherein the ultrasonic frequency ranges from about 10 to about 90 kHz.14. The method according to claim 13, wherein the ultrasonic frequencyranges from about 15 to about 50 kHz.
 15. The method according to claim2, wherein the ultrasonic energy comprises a signal amplitude in therange from about 1 μ to about 125 μ.
 16. The method according to claim15, wherein the ultrasonic energy comprises a signal amplitude in therange from about 15μ to about 60 μ.
 17. The method according to claim 1,wherein the blank workpiece moves in a linear motion relative to thehorn.
 18. The method according to claim 1, wherein the blank workpiecemoves in a perpendicular motion relative to the horn.
 19. The methodaccording to claim 1, wherein the tool is in contact with the blankworkpiece from about 1 millisecond to about 5 seconds.
 20. The methodaccording to claim 19, wherein the tool is in contact with the blankworkpiece from about 1 second to about 3 seconds.
 21. The methodaccording to claim 1, further comprising the step of discontinuing theapplication of ultrasonic energy prior to withdrawal of the tool fromcontact with the blank workpiece.
 22. The method according to claim 1,wherein the cross-sectional geometry of the blank workpiece is selectedfrom the group consisting of round, star, square, elliptical, octagonal,rectangular, flat, and combinations thereof.
 23. The method according toclaim 1, wherein the blank workpiece is a material selected from thegroup consisting of degradable materials, non-degradable materials, andcombinations thereof.
 24. The method according to claim 1, wherein theblank workpiece comprises a degradable material selected from the groupconsisting of polyesters, polyorthoesters, polymer drugs,polydroxybutyrates, lactones, proteins, cat gut, collagens, carbonates,caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide,homopolymers thereof, copolymers thereof, and combinations thereof. 25.The method according to claim 1, wherein the blank workpiece comprises anon-degradable material selected from the group consisting ofpolyethylene, polypropylene, polyamides polyamines, polyimines,polyesters, polytetrafluoroethylene, polyether-esters,polytetramethylene ether glycol, 1,4-butanediol, polyurethanes, silk,collagen, cotton, linen, carbon fibers, homopolymers thereof, copolymersthereof, and combinations thereof.
 26. The method according to claim 1,further comprising the step of applying a coating on at least a portionof the blank workpiece.